| Part I Research on vertebral augmentation using high-viscosity PMMA cement for 3D model of thoracolumbar vertebraeObjective: To establish the thoracolumbar osteoporotic vertebral compression fractures(OVCFs)models using 3D printing technology and observe the injection,distribution and leakage of high-viscosity PMMA cement and low-viscosity PMMA cement in the 3D models.In order to provide research models and guide surgical therapy for percutaneous vertebroplasty(PVP)and percutaneous kyphoplasty(PKP)for the treatment of OVCFs.Methods: 15 cases of elderly patients with thoracolumbar OVCFs were selected.CT scans were made for the thoracolumbar regions.The original data in Dicom format of CT was copied and analyzed by Watson Surgical planning system software to establish the 3D models of thoracolumbar vertebrae.Unwanted sections were removed on the computer and then the 3D image of T11-L3 was entered into the 3D printer to make the 3D models.Furthermore,the 3D models were made into compression fracture models.Unilateral and bilateral PVP were performed and the working channels were inserted into vertebral body,and the high-viscosity cement was injected into each of the 25 vertebrae.Bilateral PKP was performed with 25 vertebrae,and the low-viscosity cement was injected after balloon dilatation.The injection,distribution and leakage of high-viscosity cement and low-viscosity cement in the 3D models were observed.Results: High-viscosity cement spreads uniformly in the vertebrae of 3D models.High-viscosity cement leakage was observed 3 of 25 vertebrae(12.0%)in unilateral PVP,9 of 25 vertebrae(36.0%)in bilateral PVP.Low-viscosity cement leakage was observed 11 of 25 vertebrae(44.0%)in bilateral PKP.There was significant difference in cement leakage between unilateral PVP and bilateral PKP(p < 0.05).Conclusion: 1.The establishment of thoracolumbar OVCFs models using 3D printing technology can be mass-produced and saving cost.2.Compared with low-viscosity cement bilateral PKP,high-viscosity cement unilateral PVP can reduce the cement leakage rate,which provides a theoretical basis for further clinical research.3.3D model is not accurate enough and the material can not fully simulate the bone.It is necessary to further improve the printing accuracy and develop better printing materials.Part II Clinical study of PKP for the treatment of OVCFsObjective: To observe the clinical effect of PKP for the treatment of OVCFs.Methods: Retrospective analysis of 150 cases of elderly patients with thoracolumbar OVCFs treated with PKP.The anterior vertebral body height,kyphotic Cobb angle,and cement leakage were analyzed by methods of radiography before and after operation.The pain and health status were evaluated by visual analogue scale(VAS)scores and Oswestry Disability Index questionnaire(ODI)scores before and after operation.Results: The total 150 operations were successfully completed.The mean follow-up period was 15 months(6 to 36 months).Cement leakage occurred in 47 cases,including 26 cases at cortical leakage,14 cases at intervertebral space leakage,4 cases at venous leakage,3 cases at epidural leakage.Back pain of most patients was obviously relieved after surgery.Some patients remained mild back pain and discomfort,which were relieved by non-steroidal anti-inflammatory drugs(NSAIDS).There was no vascular injury,nerve injury,pulmonary embolism and serious complications.The percentage of anterior vertebral body height was(62.21±7.68)% preoperatively and(87.11±5.35)%postoperatively and ended up with(84.15±5.25)% at final follow-up.The average kyphotic Cobb angle improved from(11.06±6.26)° preoperatively to(7.51±3.40)° postoperatively and to(8.72±3.42)° at final follow-up.The VAS score decreased from(7.79±1.14)preoperatively to(2.21±0.51)at 2 days after operation and to(1.92±0.65)at final follow-up.The ODI score was(45.5±1.4)preoperatively and(16.1±2.1)postoperatively and ended up with(7.0±1.0)at final follow-up.There were significant differences in anterior vertebral body height,kyphotic Cobb angle,VAS scores and ODI scores between pre-and post-operation(P < 0.05).Conclusion: PKP can effectively relieve the pain,improve the clinical symptoms,andrecover the anterior vertebral height and kyphotic Cobb angle of OVCFs.Part III Prospective study of unilateral PVP with high-viscosity cement for the treatment of OVCFsObjective: The aim of this study was to evaluate the clinical effect and introduce the operation technique of unilateral PVP using high-viscosity cement for the treatment of OVCFs.Methods: Between January 2014 and December 2015,twenty-five patients with OVCFs were treated with unilateral PVP using high-viscosity cement.Operation time,number of X-ray irradiation,and cement injection volume were recorded.The anterior vertebral body height,kyphosis Cobb angle,cement distribution and cement leakage were analyzed by methods of radiography.The VAS scores and ODI scores were used to evaluate pain and health status.Results: No vascular injury,nerve injury and pulmonary embolism were observed.The average operation time was(41.7±11.4)min per vertebral body(range: 20-60 min).The average number of X-ray irradiation was(47.0±14.8)times per vertebral body(range:39-99 times).The average cement injection volume was(4.0±0.8)ml(range: 3-6 ml)per vertebral body.The cement distribution in the vertebral body was uniform.Asymptomatic cement leakage occurred in 4 cases(4/29,13.79%).No venous leakage was observed.Pain in all patients was obviously relieved.There were significant differences in the anterior vertebral body height,the kyphosis Cobb angle,the VAS scores and the ODI scores between pre-and post-operation(P < 0.05).Conclusion: The unilateral PVP with high-viscosity cement has a simple procedure and the safety and efficacy have been confirmed.The high-viscosity cement spread uniformly in the vertebral body,which can stabilize the compression vertebral body and significantly relieve pain,improve activity.Part IV Comparison of high-viscosity cement PVP and low-viscosity cement PKP for thetreatment of OVCFsObjective: The aim of this prospective study is to evaluate the clinical effect and safety of unilateral PVP using high-viscosity cement(UPVP),bilateral PVP using high-viscosity cement(BPVP),and bilateral PKP using low-viscosity cement(BPKP)for the treatment of OVCFs.Methods: A total of 75 patients with OVCFs were randomized treated with UPVP(n=25),BPVP(n=25)and BPKP(n=25).Operation time,fluoroscopic times,and cement injection volume were recorded.The vertebral body height,kyphotic Cobb angle,cement distribution and cement leakage were analyzed by methods of radiography.The VAS scores and ODI scores were used to evaluate pain and health status.Results: The operation time and fluoroscopic times in UPVP group were significantly less than that in BPKP group(P < 0.05).Asymptomatic cement leakage was observed 4 of29 vertebrae(13.79%)in UPVP group,11 of 27 vertebrae(40.74%)in BPVP group and 15 of 31 vertebrae(48.39%)in BPKP group.There was significant difference in cement leakage between unilateral and bilateral vertebral augmentation groups(p < 0.05).No venous leakage was observed in UPVP and BPVP groups.The vertebral body height,kyphotic Cobb angle,VAS scores,and ODI scores were significantly improved after UPVP,BPVP,and BPKP treatments(P < 0.05).There were no significant differences in vertebral body height,kyphotic Cobb angle,VAS scores,and ODI scores between UPVP,BPVP,and BPKP groups(P > 0.05).Conclusion: All surgical methods were safe and efficient for the treatment of OVCFs.Compared with BPKP,UPVP provided a simple procedure,and significantly reduced operation time,fluoroscopic times,and cement leakage.The initial outcomes suggest that UPVP may be better than BPVP and BPKP. |
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